Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase

Alzheimer Disease Clinical Trial

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Official title:

Enhancing Sleep Quality for Nursing Home Residents With Dementia: Pragmatic Trial of an Evidence-Based Frontline Huddling Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05820919
• Other study ID #: R33AG065619
• Status: Recruiting
• Phase: N/A
• Start date: September 7, 2023
• Est. completion date: May 29, 2027

Study information

• Verified date: March 2024
• Source: University of Alabama, Tuscaloosa
• Contact: Lynn Snow, PhD
• Phone: 205-201-0312
• Email: LSNOW[@]ua.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study seeks to improve clinical outcomes for an important, growing, and vulnerable population-nursing home residents with Alzheimer's disease or related dementias-by testing an evidence-based intervention to improve these residents' sleep. It will also examine the implementation and sustainment of this intervention.

Description:

Disturbed sleep places older adults at higher risk for frailty, morbidity, and even mortality. Yet nursing home (NH) routines frequently disturb residents' sleep through use of noise and light or efforts, for example, to reduce incontinence. NH residents with Alzheimer's disease or related dementias-almost two-thirds of long-stay NH residents-are likely to be particularly affected by sleep disturbance. This study tackles these important issues and substantially moves forward goals of the National Plan to Address Alzheimer's Disease 2018 Update by proposing to implement an evidence-based intervention to improve sleep: a NH frontline staff huddling program known as LOCK. The LOCK program is derived from evidence supporting strengths-based learning, systematic observation, relationship-based teamwork, and efficiency.

This is an incomplete stepped-wedge randomized controlled trial to test the impact and sustainability of the LOCK sleep program. In 24 community nursing homes (NHs)-eight from each of 3 national NH corporations-our multi-disciplinary team will examine these aims: (1) Implement the LOCK-based sleep program for residents with ADRD using the train-the-trainer model. (2) Estimate impact of the LOCK sleep program on sleep (primary outcome) and on psychotropic medication use, pain and analgesic medication use, and activities of daily living decline (secondary outcomes). (3) Examine factors, using mixed methods, associated with variation in the program's implementation and its sustainability.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 456
• Est. completion date: May 29, 2027
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Nursing home residents aged >=50 years with an Alzheimer disease or related dementia (ADRD) diagnosis, identified by nursing home staff participating in frontline LOCK sleep huddles as having sleep problems

Exclusion Criteria:

• Residents with a high risk of OSA who are not being treated for OSA because actigraph measurements are inaccurate in that population.

• Residents who have a persistent bilateral resting tremor or paralysis in both arms (a subset of persons with Parkinson's disease and related significant tremor-causing diagnoses), due to actigraph measurement inaccuracies

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia
• Dyssomnias
• Parasomnias
• Sleep Disorder
• Sleep Disturbance
• Sleep Wake Disorders

Intervention

Behavioral:
• LOCK Sleep Program
The LOCK sleep program is a program that trains NH staff in a NH frontline staff huddling approach. It is derived from evidence supporting strengths-based learning, systematic observation, relationship-based teamwork, and efficiency. Staff learn how to work together as a team to collaboratively problem-solving about resident sleep challenges (e.g., evidence-based sleep promoting best practices and daytime meaningful activity best practices).

Other:
• No intervention (control period/baseline data collection)
Each NH serves as its own control. During the control period, baseline data will be collected.

Locations

Country	Name	City	State
United States	Vivage/Beecan Corporation	Lakewood	Colorado
United States	National HealthCare Corporation	Murfreesboro	Tennessee
United States	Caraday Healthcare, LLC	San Marcos	Texas

Sponsors (5)

Lead Sponsor	Collaborator
University of Alabama, Tuscaloosa	Brown University, The University of Texas Health Science Center, Houston, University of Massachusetts, Lowell, University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep (actigraph measurement)	Total sleep time (total minutes asleep each nighttime period - 10pm to 7am)	15 week sleep intervention period
Secondary	Psychotropic medication use	As recorded in the Minimum Data Set's Medications received subscale, Antipsychotic medication question, and Psychotropic Drug Care Area Trigger Code. The Medications received subscale asks if the resident has received any antipsychotic, antianxiety or antidepressant medication in the past seven days or since admission/reentry if less than seven days. The Antipsychotic medication, similar to in the previous subscale, asks whether the resident received antipsychotic medications since admission/entry or reentry or the prior OBRA assessment, whichever is more recent. Finally, the Psychotropic Drug Trigger Code asks whether the Psychotropic Drug Use Care Area was triggered. These are MDS items N0410A-C, N0450A, and V0200A17A, respectively. These data will be consolidated into a trichotomous indicator of change from baseline (decrease, increase, same).	15 week sleep intervention period
Secondary	Pain treatment received	Based on the Pain Management items as recorded in the Minimum Data Set. The Pain Management sub scale asks, using yes or no questions, if the resident has been on a scheduled pain medication regimen, received PRN pain medication or was offered and declined, and, has received non-medication intervention for pain in the past five days. These data will be consolidated into a trichotomous indicator of change from baseline (decrease, increase, same).	15 week sleep intervention period
Secondary	Pain - Resident Report	Based on the Pain Assessment items as recorded in the Minimum Data Set. The Pain Assessment sub scale asks if the resident has had pain or hurting (yes, no), the frequency of pain or hurting (almost constantly, frequently, occasionally, rarely), if the resident had difficulty sleeping because of pain or hurting (yes, no), if the residents day-to-day activities were limited because of pain or hurting (yes, no) over the past five days. The Pain Intensity sub scale asks the residents numeric pain rating value (0-10 scale) and intensity of worst pain experienced (mild, moderate, severe, very severe or horrible) in the past five days. These data will be consolidated into a trichotomous indicator of change from baseline (decrease, increase, same).	15 week sleep intervention period
Secondary	Pain - Staff Report	As recorded in the Minimum Data Set, the Staff Assessment sub scale asks staff members, all yes, no responses, if the resident had non-verbal sounds, verbal complaints, facial expressions, protective body movements or postures, or no signs that may be an indicator of possible pain in the last five days. These data will be consolidated into a trichotomous indicator of change from baseline (decrease, increase, same).	15 week sleep intervention period
Secondary	Activities of daily living decline	Has activities of daily living functional ability declined from baseline. Based on Minimum Data Set items assessing decline in activities of daily living (MDS; G0110A-J & G0120A-B; QM N028.01), these data will be consolidated into a trichotomous indicator of change from baseline (decrease, increase, same)	15 week sleep intervention period